TAMOXIFEN TABLETS 10MG

Transcript

PATIENT INFORMATION LEAFLET

Tamoxifen Tablets 10mg, 20mg and 40mg
(Tamoxifen Citrate)
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed
in this leaflet. See Section 4.
What is in this leaflet:

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What Tamoxifen is and what it is used for
What you need to know before you take Tamoxifen
How to take Tamoxifen

What Tamoxifen is and what it is
used for

Tamoxifen belongs to a group of medicines called
anti−oestrogens.
Tamoxifen is used to treat:
Breast cancer
Infertility in women caused by the failure to produce
eggs (ovulate)

2

What you need to know before
you take Tamoxifen

Do not take Tamoxifen if:
You are allergic (hypersensitive) to Tamoxifen, anti−
oestrogens or any of the other ingredients of this
medicine (see Section 6 "Contents of the pack and
other information")
You are pregnant or think you might be pregnant (see
"Pregnancy and Breast−feeding" section)
You are taking anastrozole, used to treat breast cancer
(see "Other medicines and Tamoxifen" section)
You are being treated for infertility and you or your
family have a history of blood clots in the veins or are
known to have an inherited (genetic) condition (defect)
Warnings and precautions
Talk to your doctor before taking Tamoxifen:
If you are taking or have previously taken Tamoxifen
and develop(ed) the following symptoms:
− vaginal bleeding
− irregular periods
− vaginal discharge
− pelvic pain or pressure

If you are at risk of developing blood clots in the veins
due to the following:
− you have breast cancer and you or your family have
a history of blood clots
− you are severely overweight (obese)
− you are elderly
− you have breast cancer and are undergoing
chemotherapy treatment
− delayed breast reconstruction surgery
− you are being treated for infertility and you are due
to have surgery or will be immobile for a long time
(as Tamoxifen should be stopped at least 6 weeks
before). Treatment with Tamoxifen should only be
restarted when you are fully mobile again
− you are being treated for breast cancer and you
are due to have surgery or will be immobile for a
long time. Treatment with Tamoxifen should only be
stopped if the risk of developing blood clots clearly
outweighs the risks of interrupting treatment with
Tamoxifen
− See Section 4 "Possible side effects, Common side
effects, Increase in risk of blood clots" for additional
information

Children and adolescents
The use of Tamoxifen is not recommended in children,
as safety and efficacy have not been established.
Other medicines and Tamoxifen
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines, including
those obtained without a prescription. This includes herbal
medicines.
Medicines which may interact with or be affected by
Tamoxifen:
Paroxetine, fluoxetine, used to treat depression
(antidepressants)
Quinidine, used to treat abnormal heart rhythms
(antiarrhythmic agent)
Cinacalcet, used to treat disorders of the parathyroid
gland (calcimimetic)
Bupropion, used to treat depression or as an aid to
stop smoking (antidepressant)
Medicines used to thin the blood e.g. warfarin
(anticoagulants)
Other medicines used to treat breast cancer, e.g.
anastrozole (non−steroidal aromatase−inhibitor) or
chemotherapy treatment
Rifampicin, used to treat bacterial infections (antibiotic)
Pregnancy and Breast−feeding
If you are pregnant or breast−feeding, think you may be

Hard to Read?

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Possible side effects
How to store Tamoxifen
Contents of the pack and other information

pregnant or are planning to have a baby, ask your doctor
for advice before taking this medicine.
Pregnancy
Do not take Tamoxifen if you are pregnant or think you
may be pregnant.
You should not try to become pregnant if you are
taking Tamoxifen. You should also try not to become
pregnant within 2 months of finishing a course of
treatment with Tamoxifen.
If you are taking Tamoxifen, you should use
non−hormonal (barrier) contraception e.g. condom,
diaphragm or coil.
Breast−feeding
Breast−feeding is not recommended if you are taking
Tamoxifen, as it is not known if Tamoxifen is passed into
breast milk.
Your doctor will decide whether you are to discontinue
breast−feeding or to discontinue your treatment with
Tamoxifen, taking into account the importance of
Tamoxifen treatment for you.
Driving and using machines
Although unlikely, you may feel tired, weak or lack energy
(fatigue) whilst taking this medicine. If any of these
symptoms are experienced, it may be necessary to avoid
driving or operating machinery or pursuing any activity in
which full attention is required.
Tamoxifen contains lactose
If you have been told by your doctor that you have
intolerance to some sugars, contact your doctor before
taking this medicine.

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How to take Tamoxifen

Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure.
These tablets are to be taken orally
Treatment of breast cancer
The recommended daily dose is 20mg.
There is no additional benefit in taking a higher dose of
Tamoxifen when being used to treat breast cancer.
Pre−menopausal women may have less frequent
periods whilst taking Tamoxifen Tablets.
Treatment of infertility
The possibility of pregnancy must be excluded before
starting treatment with Tamoxifen.
Women with regular
g
p
periods:
20mg of Tamoxifen should be taken on the second,
third, fourth and fifth day of your menstrual cycle.
If your initial course of treatment is unsuccessful, further
courses of treatment may be given during subsequent
periods, increasing the dose to 40mg and then 80mg
daily.
Women with irregular
g
p
periods:
The initial course of 20mg daily may begin on any day.
If there are no signs of period bleeding (ovulation),
another course of treatment may begin after 45 days
with the dosage increased to 40mg and then 80mg
daily.
If period bleeding (menstruation) does occur, the next
course of treatment should begin on the second day of
your menstrual cycle.
Use in children
Tamoxifen Tablets are not recommended for use in
children under 18 years of age.
If you take more Tamoxifen than you should
If you accidentally take too many tablets, contact your
doctor or nearest hospital emergency department
immediately for advice. Remember to take this leaflet or
any remaining tablets with you.
If you forget to take Tamoxifen
Take it as soon as you remember, unless it is time for your
next dose. If you miss a dose do not take a double dose to
make up for a forgotten dose.
If you stop taking Tamoxifen
It is important that you keep taking Tamoxifen for as long
as your doctor has told you to.

Phone

continued....

0800 970 6115

for help
Till−Ver.5.1s

If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

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Possible side effects

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Seek medical advice immediately if you develop the
following symptoms:
Allergic reactions: swelling of the face, throat or tongue,
fever, difficulty in breathing, dizziness
Fever, general ill feeling, itching, joint aches, multiple
skin lesions (erythema multiforme)
Blistering of the skin (bullous pemphigoid), mouth, eyes
or genitals (Stevens−Johnson syndrome)
Swelling of the deeper layers of the skin, caused by a
build−up of fluid (angiodema)
If you develop any severe side effects, your doctor may
decide to reduce your dose of Tamoxifen to less than
20mg daily to try to lessen the impact of the side effects
without affecting your treatment. If there is no improvement
following this measure, your doctor may decide to stop
your treatment with Tamoxifen.
Very common side effects (may affect more than 1 in
10 people)
Tiredness, weakness or lack energy (fatigue)
Feeling sick (nausea)
Fluid retention
Vaginal bleeding
Vaginal discharge
Skin rashes
Hot flushes
Common side effects (may affect up to 1 in 10 people)
Damage to the retina [light−sensitive tissue lining the
back of the eye] (retinopathy)
Tingling or numbness in the hand or feet (paraesthesia)
Abnormal sense of taste (dysgeusia)
Increase in risk of blood clots (especially in patients
undergoing chemotherapy treatment):
−
stroke
−
blood clot in one of the deep veins in the body
(deep vein thrombosis [DVT])
−
clots in the small blood vessels (microvascular
thrombosis)
−
blockage in a blood vessel in the lungs (pulmonary
embolism)
Signs and symptoms of blood clots depend on where the
clots form: symptoms of a blood clot in the heart or lungs
may include chest pain, shortness of breath and discomfort
in the arms, back, neck, or jaw. Symptoms of a blood clot
in the leg may include pain, redness, warmth and swelling
in the lower leg. Symptoms of a blood clot in the brain may
include headaches, speech changes, an inability to move
(paralysis), dizziness and trouble speaking or
understanding speech.
If you show any signs or symptoms of blood clots, contact
your doctor immediately.
Treatment with Tamoxifen should be stopped immediately
and appropriate anti−blood clotting measures initiated.
Your doctor will decide if treatment with Tamoxifen should
be resumed.

Leg cramps
Muscle pain (myalgia)
Increased level of fats (triglycerides) in the blood
Looking pale and feeling tired (anaemia)
Cloudy patches in the lens of the eye, causing blurred
vision (cataracts)
Non−cancerous tumours growing in or around the womb
[uterus] (uterine fibroids)
Headache
Lightheadedness
Itching of the area around the vagina [vulva] (pruritus
vulvae)
Thickening of the lining of the womb (endometrial
hyperplasia) causing symptoms such as abnormal
vaginal bleeding
Small, soft growths (polyps) on the lining of the womb
(uterus)
Hair loss (alopecia)
Being sick (vomiting)
Diarrhoea
Constipation
Changes in liver enzyme levels (can be detected by
blood tests)
Build−up of excess fats in the liver (fatty liver)

Uncommon side effects (may affect up to 1 in 100
people)
If you suffer from bone cancer (bony metastases) you
may develop high levels of calcium in the blood
(hypercalcaemia) on starting treatment with Tamoxifen
Inflammation of the lungs (interstitial pneumonitis)
Increased risk of womb (uterus) cancer (endometrial
cancer)
A reduction in blood platelets, which increases risk of
bleeding or bruising (thrombocytopenia)
A reduction in white blood cells (leucopenia)
Visual disturbances
Inflammation of the pancreas (pancreatitis)
Scarring of the liver as a result of continuous, long−term
liver damage (cirrhosis)

A reduction in white blood cells (neutropenia)
Increased risk of cancer of the muscle and supporting
tissues of the womb [uterus] (uterine sarcoma)
Inflammation of the optic nerve causing blurring, blind
spots, distorted vision, reduced colour vision and pain
when moving the eyes. In a small number of cases
blindness may occur (optic neuropathy/optic neuritis)
Increase in the size of tumours (tumour flare)
Inflammation of the liver (hepatitis)
Build−up of bile acids in the bloodstream causing
persistent itch (cholestasis)
Liver failure or damage (hepatocellular injury/hepatic
necrosis)
Inflammation of the blood vessels in the skin causing a
rash (cutaneous vasculitis)
Condition where small pieces of the womb lining are
found outside the womb causing symptoms such as
painful periods, persistent pain in the pelvic area and
infertility (endometriosis)
Swelling of ovarian cysts (growth on, or inside, the
ovary) in pre−menopausal women being treated with
Tamoxifen
Small, soft growths (polyps) on the vagina
More prone to infections due to a severe reduction in
number of white blood cells (agranulocytosis)
Very rare side effects (may affect up to 1 in 10,000
people)
Condition which causes joint pain, skin rashes and
fever (Cutaneous Lupus Erythematosus [CLE])
Sensitivity of the skin to sunlight (Porphyria Cutanea
Tarda [PCT])
Other side effects (frequency not known)
Stomach pain or discomfort
If you are taking Tamoxifen to treat breast cancer, your
blood platelet count may fall
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly via the internet at www.mhra.gsi.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

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How to store Tamoxifen

Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date, which is
stated on the carton/blister after EXP. The expiry date
refers to the last day of that month.
Protect from heat. Store in the original package in order
to protect from light and moisture.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help to protect the environment.

Contents of the pack and
other information

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What Tamoxifen contains:
Each 10mg tablet contains 15.2mg of Tamoxifen citrate.
Each 20mg tablet contains 30.4mg of Tamoxifen citrate.
Each 40mg tablet contains 60.8mg of Tamoxifen citrate.
The other ingredients are: lactose, microcrystalline
cellulose, carmellose sodium, povidone, magnesium
stearate, potable water.
What Tamoxifen look like and the contents of the pack:
Tamoxifen 10mg are white, convex tablets printed with
"T10" on one side with an approximate diameter of
8mm.
Tamoxifen 20mg are white, convex tablets printed with
"T20" on one side with an approximate diameter of
9.5mm.
Tamoxifen 40mg are white, convex tablets printed with
"T40" on one side with an approximate diameter of
12.5mm.
Tamoxifen is available in:
Tamoxifen tablets are available in packs of 30, 50 or 100
tablets.
Not all pack sizes may be marketed.
Product Licence Numbers:
Tamoxifen Tablets 10mg: PL 11311/0517
Tamoxifen Tablets 20mg: PL 11311/0059
Tamoxifen Tablets 40mg: PL 11311/0518
Marketing Authorisation Holder & Manufacturer:
Tillomed Laboratories Ltd.
3 Howard Road,
Eaton Socon,
St Neots,
Cambridgeshire
PE19 8ET
UK
This leaflet was last revised in June 2014

Rare side effects (may affect up to 1 in 1000 people)
Changes to the cornea (the clear, dome−shaped,
window covering the front of the eye)

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.